Saturday, August 1, 2015

As I Hoped/Predicted Yesterday -- Guinea Will "Ring Vaccinate" Ebola Node Contacts -- From Now On

And the Health Ministry in Guinea is doing so with WHO blessing, it seems. Excellent. Only a matter of time before Sierra Leone and Liberia join in.

This moment, August 1, 2015, is likely the end of large-scale Ebola outbreaks -- in Africa (and globally) -- in much the way polio was eradicated in most of the world about 75 years ago. Late in coming, to be sure, but this is a triumphant moment for the power of biological science, applied. More later, but Here is Bloomberg on it all:

. . . .Guinea will inoculate all people who have come into contact with new cases of Ebola after successful trials of a vaccine developed by Merck & Co., the head of the campaign against the virus said.

Guinea’s government, the World Health Organization and the medical charity Doctors Without Borders began a series of trials of the VSV-EBOV vaccine in the West African nation on March 7, National Coordinator of the Fight against Ebola in Guinea Sakoba Keita told reporters Friday in the capital, Conakry.

"The vaccine showed a 100 percent efficacy," Keita said. "From today, all the contacts will be vaccinated so as to stop the evolution of the virus. . . ."

This is quite welcome Saturday morning news!

Friday, July 31, 2015

Ebola Vaccine Good News: 100 Per Cent Efficacy; Phase III Effort Continues

The focus now shifts to SAGE -- and how soon that arm of the World Health Organization will recommend the candidate be used in wide scale vaccination efforts, in country.

We do know there had been a lingering (albeit small-scale) re-appearance/outbreak in Guinea -- and more recently, outside Monrovia, Liberia. Might the vaccine now be deployed in a ring fashion, among the 20 or so known to be exposed? I think that a very wise next step. Here is Bloomberg's reporting overnight:

. . . .Merck & Co.’s vaccine for Ebola is “highly effective,” according to an interim analysis from a panel of experts who recommended that a late-stage trial should continue.

The vaccine was 100 percent effective when it was tested on more than 4,000 people who were in close contact with Ebola patients in the African nation of Guinea, according to a study published today in the Lancet medical journal. . . .
As the authors of the original study put it, in The Lancet (with a hat tip to my erstwhile anonymous commenters, too!) then: ". . ."One important message [here] goes beyond even Ebola — the power of multilateralism and inclusive partnership to devise and execute critical clinical research. . . . Ebola has been a catastrophe for west Africa. But out of this epidemic has come the opportunity to build unprecedented collaborations to generate evidence to advance health. There have been few better examples to prove the value and importance of WHO to strengthen global health security. . . ." Quite so. It's just long time, in coming, sez me.

And so -- a hopeful summer Friday begins, just as August is upon us. Onward.

Thursday, July 30, 2015

Pharma's Latest Trans-Pacific Trade Treaty Negotiating Points -- NYT's Excellent Update From Hawaii

I will commend this fine long form piece to the attention of our readership. [Our own latest backgrounder is here, from June 2015. It is likely true that whatever deal is reached here, will become the default world wide trade standard -- in around five years' time -- so, the stakes are truly titanic.] I'll take no absolutist positions on any of these issues, as I note there are compelling policy and economic arguments, on all sides. But I do think the US Congress ought to harmonize biologics' patent protection periods -- at around seven years. [Sly smile.]

The New York Times' morning reporting nicely summarizes the manifold pressures being exerted -- on all sides -- in the battle over what pharma and biologic patent protections, and market access for imitators will look like, if a deal is struck, in the current round, in Lahaina, Hawaii. Most significantly, Australia is seeking only five years of patent protection on biologics, while the US remains at 12. That alone could be a deal breaker. Do go read it all -- from this morning's Gray Lady:

. . . .The complexity of the pharmaceutical issues illustrates how difficult it will be to agree on broad trade rules for 12 countries, including giants like the United States and Japan and developing counties like Peru, Malaysia, communist Vietnam and tiny Brunei. . . .

[M]edicines remain a delicate problem, and if Japan’s last stand is on rice and Canada’s is on dairy, the United States’ might be on pharmaceuticals.

About 5,600 medicines are in development in the 12 TPP countries, with 3,372 of them in the United States, including more than 900 biologics, which are grown from live cells, according to the Senate Finance Committee. The industry contributes nearly $800 billion to the United States economy each year. . . .

Negotiators already seem to be backing away from the hard-line United States position. Observers to the negotiations say the 12-year patent window almost certainly will be scaled back to five to seven years, a move that will anger both the pharmaceutical firms and their allies, and the activists. The Pacific accord is structured so that other countries can join in the future, and the belief on both sides of the pharmaceutical fight is that once 12 nations ratify rules, they will become international standards. . . .

United States law protects pharmaceutical patents for 12 years, allowing drug makers to recoup their research-and-development investments before generic companies can come in with far cheaper versions. Negotiators for the United States say they are obligated to defend American law, even though President Obama has been pushing to shorten the patent protection to seven years. . . .

Onward, on a perfect Thursday -- and if I had to bet, I'd wager that the TPP deal will get done -- at seven years, on biologics. The costs of a "no treaty" outcome are just too steep, for all nations. Enjoy your Thursdays -- one and all -- starting to swelter, already here!

Tuesday, July 28, 2015

Other Q2 2015 Release Updates: Hep C Candidate Grazoprevir/Elbasvir Granted Priority FDA Review -- Decision By January 2016

So as not to be lost in the shuffles -- of revised guidance, Venezuelan charges and the smallish Israeli oncology candidate acquisition. . .

I will separately post on the next gen, once daily combo tab for Hep C Merck is advancing through Phase III, now. FDA has received the packet, and will likely make a decision on it early in 2016. However, Kenilworth already faces some daunting competitors in this space. Just the same, this is moderately good news:

. . . .Separately, Merck said, the U.S. Food and Drug Administration has accepted for review the company’s new drug application for grazoprevir/elbasvir, a once-daily, single-tablet therapy for hepatitis C. The agency granted priority review for the treatment with a decision expected by Jan. 28 [2016]. . . .

And, just as expected Remicade tok a hit from biosim introductions this quarter. That will accelerate in future quarters. Onward. . . .

Merck Full Year 2015 GAAP Guidance Hit By Venezuelan Deval; Deal Costs

Kenilworth just reported Q2 2015 results. More soon, but the biggest driver is a $715 million charge -- to the Venezuelan currency carrying values. More broadly, Merck saw a seven per cent downdraft, due to the strong dollar (effect of weak foreign currencies), at the sales line. Listening to the webcast now.

While it raised the full year non-GAAP guidance range for EPS (a feel-good measure by and large), Merck lowered its full-year GAAP EPS guidance, due to the Venezuelan deval charge, and costs of M&A of late. That's not welcome news, but had been widely expected.

In a separate release, Merck said it spent modestly to acquire another set of promising cancer pipeline candidates out of Israel, called cCAM Biotherapeutics:

. . . .Under terms of the agreement, Merck, through a subsidiary, will acquire all outstanding stock of cCAM in exchange for an upfront payment of $95 million in cash. In addition, cCAM shareholders of record are eligible to receive a total of up to $510 million associated with the attainment of certain clinical development, regulatory and commercial milestones. The transaction is subject to certain closing conditions. . . .

More later -- graphics soonKeytruda is showing a nice sales ramp in melanoma in the U.S., where it is the number one therapy -- but that is the smaller burden cancer set -- since BMS holds the lead in lung cancers. Do keep in mind, as Dr. Perlmutter talks, that BMS is around a year ahead on most fronts, in the highest burden cancers. Morning -- one and all!

Sunday, July 26, 2015

Merck Will Report Q2 On Tuesday; Some Color From BMS's Views On Newest Immuno-Oncology Agents

UPDATED -- 07.26.15 @ 1 PM EDT: As to the predicted numbers, here is Forbes on it all -- ". . .Analysts are forecasting lower quarterly profits compared with last year’s, at $0.80 a share from sales of $9.78 billion, partially because of its 58% forex exposure. In the year-ago period, MRK made per-share earnings of $0.85 and $10.9 billion in revenue. However, Wall Street hasn’t been great at nailing MRK. If history repeats itself, Merck’s results could beat expectations like it has in 10 of the last 11 quarters. . . ." Now we wait. End, updated portion.

To be sure, we will have to wait and see what the release on Tuesday morning harbors, but I'd not expect a nine per cent downdraft, at the sales line, due to currencies, as was seen last week at Bristol Myers Squibb. I think Merck has more hedging in place than BMS, and a better "natural" mix of geographies; and product-margins (each of which ought to dampen currency headwinds somewhat, at Merck).

What I see as one of the most hopeful moments, likely to be echoed on the Kenilworth call, Tuesday, is the notion that (thus far, at least) Opdivo® (and by implication, Keytruda®) won't see strong payer-side pressure to agree to long term contracts, with significant price discounts, in any cancer set -- anytime in the near (24 month) future. And this is potentially a $35 billion market opportunity, all in. On the BMS call, the question about potential for a Sovaldi® type of pressure/backlash from government- and private insurer- payers was answered thus:

. . . .We've really been fortunate with the quality of data that have been generated behind Opdivo and the value that we've been able to establish for patients with metastatic melanoma and non-small cell lung cancer. And I think that's been recognized by payers. We've had -- we have established very broad and very rapid access in the US.

The breadth of indications that we hope will follow will also further strengthen our ability to weather any attempt that any payers may have to try to restrict these agents, which is very difficult to do in the oncology arena with drugs like Opdivo with overall survival benefits. So we feel very good about our current access and our ability to sustain that going forward. . . .

It would be hard for an insurer to defend being restrictive where the data shows that people will literally die much sooner, without access to the therapy. And that is -- in the main -- what this data establishes -- at both Merck, and BMS. This should mean similar, but smaller, good news ahead for Merck. Keep in mind that in BMS was first to market, and that (at least I predict) Merck will eventually offer to cut price on Keytruda, to win some of the BMS share, in the markets where Merck is likely a year or so behind. Just my $0.02. Onward.

Saturday, July 25, 2015

Merck's Retiring EVP & GC Gets Enhanced Departure Vesting -- Purportedly To Enter Public Sector(?!)

In general, I've held the opinion that Merck has greatly reformed the company's executive perks and pay practices -- especially those that used to prevail at legacy Schering-Plough. [Afterall, this Merck IS the Schering-Plough legacy Delaware holding company, just renamed -- with Merck's legacy assets folded in. In fact, Merck installed double triggers, for all its executive payouts, back when legacy S-P barely had a meaningful "single trigger". Remember, by 2006, Merck was pulling EARNINGS that regularly TRIPLED S-P's, despite carrying a much bigger base. For all of this, then CEO Clark earned less than a third (per year) of what that shine-ola salesman Hassan took from legacy Schering-Plough. But I digress.]

Having said all of that, this acceleration of Mr. Kuhlik's equity awards -- and that is what this is -- an acceleration, and fixing in cash, the certainty of those awards. . . strikes me as over the top.

I am unconvinced that -- as he retires, in normal fashion, from Kenilworth -- Merck will receive any meaningful benefit from his entering a government job. And any ordinary person in his role, would simply accept that his choices are. . . his choices -- ones that may have real pecuniary consequences, under his previously agreed retirement packages. I'll wait to see where he turns up, but if he's to become any judicial or regulatory office holder, getting a "bump" as he departs Merck would seem inappropriate. I am sure he was a very capable GC -- but tearing up his retirement agreement, especially where (as here) he is not really retiring at all. . . seems a lil' like a Fast Fred Hassan move, truthfully. Here's the bulk of the late Friday evening (i.e., buried) SEC Form 8-K:

. . . .Bruce Kuhlik, who completed his tenure as General Counsel for Merck & Co., Inc. (the "Company") on June 30, 2015, is entitled to payment of certain compensation following his retirement from the Company (which is effective August 1, 2015) under the Company’s compensation programs, the terms and conditions of which have been previously disclosed. Mr. Kuhlik has advised the Company that following his retirement, he intends to accept a position in the public sector which would require him, as a condition of his employment, to divest himself of any interests in the Company that are subject to variability based on Company performance. The Compensation & Benefits Committee (the “Committee”) of the Company’s Board of Directors determined that it was reasonable and appropriate to allow Mr. Kuhlik to realize a certain amount of income that he would otherwise have had the opportunity to be paid under the Company’s compensation plans and programs had he not been required to divest his interests at this time. Therefore, on July 21, 2015 the Committee authorized and Mr. Kuhlik has accepted changes to certain incentive compensation arrangements previously granted to Mr. Kuhlik, as follows:

1. Accelerate the vesting of that portion of the Stock Option granted to Mr. Kuhlik in 2013 (consisting of 1/3 of the original number of shares), that would have otherwise vested in connection with his retirement so that the final portion of the option is fully exercisable beginning on August 3, 2015, the first business day following Mr. Kuhlik’s retirement, rather than in May 2016. This change does not directly provide a payment to Mr. Kuhlik, but allows him to fully exercise the option in the short term.

2. Accept Mr. Kuhlik’s forfeiture of the portion of each of the stock options granted to Mr. Kuhlik in 2014 and 2015 (consisting of 1/3 of the original number of shares) that would have vested in May 2016 in light of his retirement. The forfeiture will be effective as of his August 1, 2015 retirement date. In addition, the remainder of the options granted in 2014 and 2015 (consisting of the remaining 1/3 and 2/3 of the original number of shares, respectively) will be forfeited in the normal course, also effective as of August 1, 2015.

3. Restructure the Performance Share Units awarded to Mr. Kuhlik in 2013 in respect of the performance period January 1, 2013 – December 31, 2015 (the “2013 PSUs”), in 2014 in respect of the performance period January 1, 2014 – December 31, 2016 (the “2014 PSUs”) and in 2015 in respect of the performance period January 1, 2015 – December 31, 2017 (the “2015 PSUs”) such that Mr. Kuhlik would receive a fixed payment in cash (as opposed to settlement in shares based on achievement of company performance goals) in an amount equal to the product of (x) a pro-rated number of units represented by each of the 2013 PSUs, 2014 PSUs and 2015 PSUs based on his retirement date of August 1, 2015 assuming target performance had been achieved and (y) $58.98, which is the average 60-day closing price of a share of Company common stock for the period of April 24, 2015 – July 20, 2015, the 60-trading days immediately preceding July 21, 2015. The cash payment will occur at the same time as the original distribution of shares would have occurred following the end of the applicable performance period. Payments in respect of these amendments will equal $1,828,498 in 2016, $756,654 in 2017 and $275,319 in 2018.

4. Accept Mr. Kuhlik’s forfeiture of the pro-rated bonus that would have otherwise been paid to him in March 2016 under the terms of the Company’s Executive Incentive Plan. . . .

Great work -- if one can get it. [I should point out that the above is only a fraction of his overall retirement benefit.] If he ends up as an Ambassador, weighing in on trade matters, then I can understand this move. Otherwise, not so much. Onward, on a sunny Saturday afternoon.

Friday, July 24, 2015

O/T Space Science Friday -- Musings On Periodic Tables -- And The Manifold Mysteries. . . Of One's Life

Sometimes, when I read something truly transcendent, I find myself short of breath. This is one of those moments.

I'll not spoil the surprise of it all -- it is an easy one page read -- in this Friday morning's New York Times. Do go read it all:

. . . .A few weeks ago, in the country, far from the lights of the city, I saw the entire sky “powdered with stars” (in Milton’s words); such a sky, I imagined, could be seen only on high, dry plateaus like that of Atacama in Chile (where some of the world’s most powerful telescopes are). It was this celestial splendor that suddenly made me realize how little time, how little life, I had left. My sense of the heavens’ beauty, of eternity, was inseparably mixed for me with a sense of transience — and death.

I told my friends Kate and Allen, “I would like to see such a sky again when I am dying.”

“We’ll wheel you outside,” they said. . . .

. . .a broad and ample road, whose dust is gold, and pavement stars, as stars to thee appear seen in the Galaxy, that Milky Way. . . .

-- Milton

And so it goes. . . do go read this. You will not regret it. This afternoon we will have new images of that enigmatic little dwarf planet Pluto. . . from its improbably but metaphorically perfect "heart" region. Onward -- ever, onward. . . . to a wondrous summer weekend, whose nights are powdered with stars. . . .

Thursday, July 23, 2015

Glenmark Granted A July 28, 2015 Supreme Court Hearing In India -- Sitagliptin Wars

We have been following this battle for quite a while. It involves Merck's right to protect its patents on Januvia®/Janumet® -- a leading diabetes therapy. The latest news here, is that India will entertain arguments from Glenmark, the object of which will be not only to sell off its existing finished drugs inventory, but to actually manufacture into new drug stock all the API (or raw materials) it now holds. Local reports indicate that Glenmark has on hand over 1,700 tons of API raw materials -- which would result in vastly more than just the ability to stay on-market through November 2015 (in my estimation, at least).

This will be completely fascinating to watch -- will the India courts still allow the production of what has been held to be infringing copycat drugs, against Merck's patents, in order to keep reasonably priced generics on market, in India, where some 63 million people are afflicted with diabetes -- and the vast majority of those cannot afford Merck's branded therapies? We shall see. Here is a bit from the ever-informative India outlet, on it all:

. . . .A bench comprising justices Ranjan Gogoi and N.V. Ramana agreed to hear Glenmark’s plea on 28 July. . . .

On Wednesday, Glenmark said that it had over 1,700 tonnes of existing stock of raw material left, which would be wasted if it is not allowed to manufacture their anti-diabetes drug. . . .

Of course, we will report back any outcome from the July 28, 2015 proceedings in India. And now, rise & shine, all of good will!

Wednesday, July 22, 2015

Propecia® MDL Update: On A Sampling Basis, About One Third Of Merck's Claims Of Privilege Were Inappropriate

The very able US Magistrate Judge Viktor V. Pohorelsky, sitting in the Eastern District of New York, has today ruled that -- in a statistical test sample of about 75 documents which the Propecia® plaintiffs claimed were inappropriately withheld from the earlier MDL discovery deliveries -- just over one-third were actually properly discoverable, and not protected by any attorney client (or other) privilege, as Merck had originally claimed.

The full six page PDF order is here, but the Magistrate has left for another day whether he will order a completely new review of all the privilege logs provided by Merck. He did order Merck to look anew at the withheld documents in light of his order, thus: ". . .the [Merck] defendants are urged to review the documents for which privilege has been claimed in light of the above rulings, however, and the court will address with counsel at the next conference what further procedures should hereafter be employed to assess the defendants’ claims of privilege. . . ."

In the main, then, this should result in the MDL plaintiffs' lead lawyers getting access to many more documents about the history of the problems with Propecia, as to they relate to Merck's awareness and path of responses.

All in all, a moderately good day for the plaintiffs today, out of the US Courts in Brooklyn. We are still many, many months from resolution of any sort, however. Onward -- and, sleep tight. . . .

Merck Gets EU Nod In Melanoma; BMS's Opdivo® Already On Market There

This is great news for Kenilworth, now adding the 28 member states of the EU to Canada -- and the US -- as approved Keytruda® geographical sales channels.

Yes, Opdivo® is already there -- and yes, BMS is a year ahead, in the larger burden NSCLC (lung cancer), and renal cell cancer races. But having options is an extremely important development, for the patients, and the payers. Now there is the real possibility that Merck will ultimately engage in price competition, against BMS -- to "win market share" in melanoma in the EU. And that will benefit both payers and patients.

[I suppose I should note that Keytruda was compared in these studies to BMS's last generation therapy -- not head to head, against Opdivo.] In any event, from the early morning presser, then:

. . . ."Today’s European approval supports our goal of accelerating immuno-oncology research for the benefit of patients around the world," said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. "We believe that the broad data set supporting this approval helps illustrate the significant potential of KEYTRUDA to treat advanced melanoma, a devastating disease."

"Merck has long-believed that innovation and access must go hand-in-hand, which is why we work to bring forward new innovations, and ensure access to those innovations," said Deepak Khanna, senior vice president and regional president, Europe, MSD Oncology. "Merck is committed to working collaboratively with governments and other stakeholders to ensure that KEYTRUDA will be made available to advanced melanoma patients in Europe as rapidly as possible. . . ."

And so, onward we forge, in the race to improve lives of cancer patients the world over. [Planetary science side note: A new range of Appalachian-sized mountains was just revealed in the Southwestern "Heart of Pluto". New images at NASA -- thrilling!]

Tuesday, July 21, 2015

US Judge Shadur: "Counsel For Merck And Bayer -- Meet Me At The Woodshed" And. . . "Don't Charge Merck For The Avelox® Rework!"

Well, first things first -- Senior federal District Court Judge Milton I. Shadur is a very able jurist -- and widely respected, here in Chicago -- for being very precise in his handling of courtroom decorum and practice, under the federal rules. And so -- this opinion will forever endear him to believers in plain English pleading (like myself).

Whether the plaintiffs here, Mr. and Mrs. Hobbs, have a good Avelox® products liability case is unclear, at this stage. What is clear is that the Hobbbs' claim permanent nerve damage from being prescribed Avelox, or a companion antibiotic. Under the federal rules, then, they should be given notice of whether Merck feels it has responsibility here, in Merck's Answer. After some 150 pages, Judge Shadur could not tell. And he's a very sharp man -- so he told Merck's lawyer to pay a $200 fine, and redo the entire Answer, free of charge -- and, this time, more faithfully comply with the federal rules for notice pleadings. Ouch. Here's a bit, of this priceless opinion (and the full 6 page PDF):

. . . .After all, because the real function of federal notice pleading is to identify the respects in which litigants are or are not at odds with each other, it is really thoughtless on the part of defense counsel to thrust on their adversaries and the judicial officer to whom the case is assigned the task of wading through two separate Answers, occupying just under 150 pages instead of half that number, to become informed as to any respects in which jointly represented parties are or are not on the same page and the way (if any) in which they differ. . . .

It is of course oxymoronic for a party to assert (presumably in good faith) that it lacks even enough information to form a belief as to the truth of an allegation, then proceed to deny it. Because such a denial is at odds with the pleader's obligations under Rule 11(b), that quoted language must be and is stricken from each of those paragraphs of the Answer. . . .

That then leaves for discussion the true absurdity of the vast proliferation of supposed Affirmative Defenses ("ADs"). In that respect defense counsel are first referred to App'x ¶ 5 to State Farm. But that is only the beginning, for what each pleading sets out under the caption "Separate Defenses" reveals a total misconception of what the pleading of ADs is about. . . . Both of the current Answers (including their ADs) are stricken in their entirety, with defense counsel being granted leave to file a single combined Amended Answer on behalf of both Bayer and Merck on or before August 7, 2015. Any ADs that are included in that joint Amended Answer must conform to the limitations ordered in this opinion. And lastly, no charge may be made to Bayer or Merck by their counsel for the added work and expense incurred in correcting counsel's errors. Defense counsel are ordered to apprise their clients to that effect by letters, with copies to be transmitted to this Court's chambers as an informational matter (not for filing). . . .

Gosh -- that is about as tough as I've ever seen him be. [And here's the Hobbs' 29 page complaint at law, for reference.] Onward.

Kenilworth Spends $1.85 Million On Lobbying, In Q2 2015 -- Or $4.155 Million In First Half Of 2015

The trend had been toward reduced spending, on lobbying (2013 to 2014, full years) -- and that was probably net-net, a pretty good thing. But now, as a new US Presidential (primary) election cycle gears up -- so too does the lobby spend, at Merck -- it would seem.

For the full first half year of 2014 (last year), Merck spent $3.75 million -- and only $1.33 million in the second quarter of 2014, both of which were sharp reductions from 2013 levels. Here is the detailed list (but see graphic at right for trend-line):

. . . .340B (no specific bill), Oncology education (no specific bill), adult vaccine policies (no specific bill), adolescent vaccine policies (no specific bill), DISARM (H.R. 4187), ACA Implementation (no specific bill), biosimilars (no specific bill), 21st Century Cures (H.R.6), FDA Regulatory Issues (no specific bill), general pharmaceutical industry issues, Senate HELP Innovation Draft (no bill number). . . .

Comprehensive tax reform (no specific bill), orphan drug tax credit (S.1128), R&D tax credit (no specific bill), base erosion (no specific bill), territorial tax system (no specific bill). . . .

Medicare Part D (general education, no specific bill), changes to low-income subsidy structure in Medicare Part D (general education, no specific bill), sustainable growth rate (H.R. 2, the Medicare Access and CHIP Reauthorization Act), Medicare Part B (general education, no specific bill), Preserving the Integrity of Medicare Act (H.R. 5780). . . .

Intellectual property (general education), patent reform (H.R. 9, the Innovation Act; S.632, the STRONG Patents Act). . . .

These are the matters upon which Merck itself reported having lobbied Congress from April 1 through June 30 of this year -- but that is not an all-inclusive list of the issues for which it hired lobby firms. Now you know -- nope; nothing to hide here.

Monday, July 20, 2015

At Some Point -- In The Last 60 Days. . . Too Distracted. . .

We had our millionth visitor, here. Sweet. Thank you, one and all!

I admit I was plainly too distracted to notice, precisely, who or when -- but it looks as though the 1,000,000th visitor was an EU dweller. Excellent.

Again, thank you one and all. Onward.

BMS Lands Squamous Non-Small Cell Lung Cancer Approval For Nivolumab: 28 EU Member States

This particular mid-July Monday is chock full of good immuno-oncology news for Bristol Myers Squibb, it seems.

BMS just announced that the EU has cleared Opdivo®, in a particularly wide array of lung cancers, opening a vast market to the franchise -- based on some other CheckMate series study results. Earlier this morning, BMS stopped the CheckMate -25 study early, due to superior efficacy over standard course, in certain renal cancers. Now -- at least inside the US -- we may safely bet that some oncologists will start writing off-label, for these other cancers -- relying on the data just cleared by the EMEA arm. But the meta-narrative here continues to be that Merck is at least a year behind BMS now, in several cancers, in the EU.

Here is a quote from the press release:

. . . ."With the EU approval of nivolumab, patients in Europe have for the first time in more than ten years access to an entirely new treatment modality for advanced squamous non-small cell lung cancer, which has the potential to replace the current standard of care," said Emmanuel Blin, senior vice president, Head of Commercialization, Policy and Operations, Bristol-Myers Squibb. "Bristol-Myers Squibb is passionate about changing survival expectations and the way patients live with advanced cancers, and is committed to continually deliver, with speed and urgency, new approaches to pursue this goal."

Approval is based on the results of CheckMate -017 and -063. In the Phase III CheckMate -017 study, nivolumab demonstrated superior clinical benefit across all endpoints versus docetaxel, the standard of care, regardless of PD-L1 (programmed death ligand-1) expression status, including a 41% reduction in the risk of death, significantly superior OS rate of 42% versus 24% for docetaxel at one-year and superior durable antitumor activity. In the Phase II CheckMate -063 study, nivolumab showed an estimated 41% one-year survival rate and a median OS of 8.2 months. The safety profile of nivolumab is consistent with previously-reported trials, and in Checkmate -017, is also favorable compared to docetaxel. . . .

Perfect. . . . and. . . I must say, just as we repeatedly predicted. Onward.

BMS's Opdivo® Posts A Solid 12 Month Lead, In Metastatic Renal Cell Carcinoma, Over Merck's Keytruda®: Immuno-Oncology Race

This is materially good news for Bristol-Myers. It very-likely gives the Opdivo® franchise yet another high burden cancer in which it will hold a one to two year advantage over Merck's competing Anti-PD L1 candidate. This CheckMate study (one in a series of like-named studies, in other cancers) was stopped early because the advantage was so clear, over existing options.

I would exepct that BMS will file with FDA on this data before year end -- and get clearance for renal cell carcinoma in late Q1 2016. We are seeing the face of oncology transform, and mature, overnight here. This is a $35 billion set of treatments, across all the cancers in which the BMS (and Merck) emerging offerings are likely to be of material benefit. A heady time, indeed. Here's a bit from the presser:

. . . .BMS announced that an open-label, randomized Phase III study evaluating Opdivo (nivolumab) versus everolimus in previously-treated patients with advanced or metastatic renal cell carcinoma (RCC) was stopped early because an assessment conducted by the independent Data Monitoring Committee (DMC) concluded that the study met its endpoint, demonstrating superior overall survival in patients receiving Opdivo compared to the control arm. The company looks forward to sharing these data with health authorities soon.

"The results of CheckMate -025 mark the first time an Immuno-Oncology agent has demonstrated a survival advantage in advanced renal cell carcinoma, a patient group that currently has limited treatment options," said Michael Giordano, senior vice president, Head of Development, Oncology, Bristol-Myers Squibb. "Through our Opdivo clinical development program, we aim to redefine treatment expectations for patients with advanced RCC by providing improved survival. . . ."

We have been following this race for two years solidly, now. The most recent June 2015 background is here. And. . . that's a perfect start, on this hot, moist July Monday -- so. . . onward, friends!

Saturday, July 18, 2015

No Cause For Alarm -- But European Medicines Agency Post-Hoc Review Of HPV Vaccines Announced This Past Week

The EMEA stresses that the safety and efficacy of the vaccine is considered well established, but that it is monitoring for relatively rare adverse events -- and collecting data, from multiple manufacturers.

Here's a bit from the press release:

. . . .As for all licensed medicines the safety of these vaccines is monitored by the Agency’s Pharmacovigilance Risk Assessment Committee (PRAC). The current review will look at available data with a focus on rare reports of two conditions: complex regional pain syndrome (CRPS, a chronic pain condition affecting the limbs) and postural orthostatic tachycardia syndrome (POTS, a condition where the heart rate increases abnormally after sitting or standing up, causing symptoms such as dizziness and fainting, as well as headache, chest pain and weakness).

Reports of these conditions in young women who have received an HPV vaccine have been previously considered during routine safety monitoring by the PRAC but a causal link between them and the vaccines was not established. Both conditions can occur in non-vaccinated individuals and it is considered important to further review if the number of cases reported with HPV vaccine is greater than would be expected.

In its review the PRAC will consider the latest scientific knowledge, including any research that could help clarify the frequency of CRPS and POTS following vaccination or identify any causal link. Based on this review, the Committee will decide whether to recommend any changes to product information to better inform patients and healthcare professionals. While the review is ongoing there is no change in recommendations for the use of the vaccine. . . .


Thursday, July 16, 2015

Can You Be A "Senior Advisor" To House Majority Leader Rep. Eric Cantor (R), AND Work For Williams & Jensen, PLLC -- As A PharmaCo Lobbyist?

Apparently so. Take a look at the penultimate page of that link. It was just filed with the US Senate office of disclosure -- under the Lobbying Disclosure Act -- this morning. Cheryl Jaeger is. . . "a shared employee, Office of the Speaker and Office of Virginia's Seventh Congressional District; Senior Policy Advisor, Majority Leader, Rep. Eric Cantor; Sr. Advisor, Majority Whip, Rep Roy Blunt; Prof. Staff House Committee on E&C; Sr LA to Rep. Christopher Cox. . . ."

I wouldn't have guessed that the applicable federal lobbying laws and regulations allowed this. Dual or "shared employees?" Really? I am no lobbyist regulatory lawyer, but it strikes me that allowing Williams & Jensen to lobby Congress, and Rep. Cantor, in particular, on behalf of Kenilworth, and others. . . isn't in the best interest of the citizenry -- or an open and transparent republic -- with the sole consent of the governed. Perhaps she is prevented (by rule) from lobbying any of the persons named above, directly. In any event, here is her bio -- from a coming Fall 2015 speaking engagement (presumably it is thus current, and correct) -- and yet no mention of the lobby-firm involvement. But the LD-2 filed by Williams & Jensen lists her. Odd.

. . . .Cheryl Jaeger is the senior health policy advisor to the Majority Leader of the U.S. House of Representatives, Eric Cantor. In this role, She leads the advancement of health care reform legislation to improve patient choice, lower health care costs, and expand innovation. Jaeger previously served as a senior advisor to the former Majority Whip Roy Blunt. Prior to serving as a leadership aide, Jaeger worked as a professional staff member for the Committee on Energy and Commerce. She was the lead staff negotiator of the NIH Reform Act of 2006 in addition to several other pieces of legislation. Jaeger began her tenure on Capitol Hill nearly 14 years ago as a legislative aide to former Congressman Christopher Cox. Jaeger earned a Masters in Public Policy from Georgetown University and is a graduate of the University of Virginia. . . .

I'll have more on this -- when the rest of the quarterly federal LD-2 lobby reports are filed -- in the coming five days, but it sure doesn't smell. . . quite as fresh as a Summer rain, to me. . . .

Maybe someone in the readership better understands lobby lawyering here -- is this relatively common, across other industries? Am I just out of touch, on this issue?

Much Sadder News -- From Africa -- Our Cradle: Now Six New Ebola Cases In Liberia; Two More Deaths

From the truly transcendent and joyous news of yesterday -- a space odyssey, likely some two million years after homo habilis first wandered about in Eastern Africa -- to far sadder developments, in the state of affairs, in Paynesville, Liberia -- this morning. We (as a planet) need to better protect our own cradle, people.

The story: yet another of the latest six patients, in the post May 2015 re-appearance of the Ebola virus, has died. This makes NewLink/Merck's effort to prove out an effective safe vaccine all the more urgent -- per The Gray Lady, herself, then -- a bit:

. . . .Even though her name was on a contact list, monitors at first failed to detect that the woman had become symptomatic, according to Tolbert Nyenswah, a deputy minister who heads Liberia’s Ebola response system.

The woman, who was the sixth Liberian to become infected since May 9, was being quarantined in her family home in Paynesville, a city on the edge of Monrovia. Another member of the household who had been infected was removed from the home earlier. According to the health officials, all six of the Ebola patients were part of the same cluster as a 17-year-old man whose body tested positive for the virus before he was buried in another community a short distance from Liberia’s international airport.

According to health care workers, people whose names are on the contact list and are under quarantine are supposed to be visited daily by monitors who take their temperature and assess their health. Mr. Nyenswah said the woman had reportedly taken medicine to suppress her fever, and he ordered an investigation to determine “what went wrong with this case that somebody was on a contact list, that they were not picked up immediately.” He said monitors were being retrained to assess each contact’s overall condition.

"She was home, and the home was being monitored," Mr. Nyenswah said. "People should not panic and be afraid". . . .

It was July first when last we mentioned this unfolding human tragedy. If we can hit a 100 by 150 kilometer box, from three billion miles out, and do so over a period of nine plus years, and then retrieve the data at a KB a second, henceforth. . . we simply must find the will (and economic and scientific ability) to vaccinate the people living in poverty in our own cradle, against this dread curse. To do any less would be. . . inhumane.